Rapid Research in the CHILD Cohort to Inform Canada's Response to the COVID-19 Pandemic: Investigating the Prevalence & Predictors of SARS-CoV-2 Infection and the Health & Psychosocial Impact of the COVID-19 Pandemic on Canadian Families.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Manitoba
- Enrollment
- 5,385
- Locations
- 1
- Primary Endpoint
- Real-Time data on SARS-CoV-2 infection, severity, transmission and immune response
Study Overview
Brief Summary
The objective of this study is to determine the prevalence and transmission of SARS-CoV-2 infection among Canadian children and parents in the CHILD cohort, identify predictors of infection susceptibility and severity, and understand the health and psychosocial impacts of the COVID-19 pandemic on CHILD families.
Detailed Description
Study will leverage the existing CHILD Cohort Study. All household members from each family will be incited to participate. To accommodate institutional physical distancing policies, the study is designed to minimize participant contact and the need for research staff onsite.
Weekly symptom check (by text message): Brief survey will capture COVID-19 signs and symptoms, testing and results, and healthcare utilization. Questions will be aligned with the Government of Canada self-assessment tool and harmonized with international partners.
Quarterly CoRonavIruS Health Impact Survey (CRISIS) (7) and body weight: 10-minute CRISIS survey captures COVID-19 exposure, life changes due to the COVID-19 crisis, daily behaviours, emotions and worries, media use and substance use. Each household member will complete the survey; parents will complete on behalf of younger children. Body weight (measured at home) will also be reported.
Repeated seroprevalence survey: Use of simple home sampling kit containing volumetric absorption micro-sampling devices (Mitra(R) cartridge device, Neoteryx LLC) to collect a fingerstick blood sample (10 ul; a few drops) for SARS-Cov2 IgG serology testing laboratory. Knowledge Users (Public Health authorities) and virology/serology experts will advise on the best available serology assay at the time of testing, and the investigators will consider testing in a public health lab if possible. Kits will be delivered and returned by mail, and an instructional video will be provided. Results will be returned to participants with appropriate explanation of their clinical relevance, and shared in real time with Knowledge Users to inform modeling efforts and pandemic management The timing and frequency of sero-surveys will be guided by our Knowledge Users depending on the progression of the pandemic.
Analysis of recently-collected pre-pandemic bio-samples: To determine the pre-pandemic immune profile of CHILD index children, the investigators will analyze a subset including all cases (asymptomatic and symptomatic) detected by serology and symptom surveys, plus a random subset of uninfected controls (estimated: 400 children in total). The investigators will assess:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All study participants enrolled in the original CHILD Cohort study are eligible for this add-on study
- •Individuals living in the same household as study participants enrolled in the original CHILD Cohort Study are also eligible for this add-on study
Exclusion Criteria
- •CHILD Cohort Study participants who have been previously withdrawn from the study are not eligible for this add-on study
- •CHILD Cohort Study participants who have not agreed to future contact by the study team are not eligible for this add-on study
- •Participants (with the exception of children) who are not able to provide consent on their own behalf are not eligible for this add-on study
- •Participants (with the exception of children) who are not able to read, write and understand English are not eligible for this add-on study
- •Participants residing outside of Canada will not be participating in the sample collection component of this study
Outcomes
Primary Outcomes
Real-Time data on SARS-CoV-2 infection, severity, transmission and immune response
Time Frame: Biweekly, up to 70 weeks from Dec 2020 through Mar 2022
Weekly Symptom check (by text message) Brief survey will capture COVID-19 signs and symptoms, testing and results, and healthcare utilization. Questions will be aligned with the Government of Canada self-assessment tool and harmonized with international partners
Identify biological and sociodemographic predictors of SARS-CoV-2 infection
Time Frame: Quarterly (once every 3 months - total duration 12 months), from Dec 2020 through Mar 2022. Baseline survey (Dec - May 2021); Follow-up 1 Survey (July - Aug 2021); Follow-up 2 Survey (Oct - Dec 2021); Follow-up 3 (Jan - Mar 2022)
Quarterly CoRonavIruS Health Impact Survey (CRISIS) (7) and body weight: The 10-minute CRISIS survey captures COVID-19 exposure, life changes due to the COVID-19 crisis, daily behaviours, emotions and worries, media use and substance use. Each household member will complete the survey; parents will complete on behalf of younger children. Body weight (measured at home) will also be reported.
Understand the psychosocial, health and equity impacts of the COVID-19 pandemic and its management on CHILD families, and identify equity impacts
Time Frame: Quarterly (once every 3 months - total duration 12 months), from Dec 2020 through Mar 2022. Baseline survey (Dec - May 2021); Follow-up 1 Survey (July - Aug 2021); Follow-up 2 Survey (Oct - Dec 2021); Follow-up 3 (Jan - Mar 2022)
Quarterly CoRonavIruS Health Impact Survey (CRISIS) (7) and body weight: The 10-minute CRISIS survey captures COVID-19 exposure, life changes due to the COVID-19 crisis, daily behaviours, emotions and worries, media use and substance use. Each household member will complete the survey; parents will complete on behalf of younger children. Body weight (measured at home) will also be reported.
Determine pre-pandemic immune profile of CHILD index children
Time Frame: 12 months
Analysis of recently-collected pre-pandemic bio-samples: To determine the pre-pandemic immune profile of CHILD index children, we will analyze a subset including all cases (asymptomatic and symptomatic) detected by serology and symptom surveys, plus a random subset of uninfected controls (estimated: 400 children in total). The investigators will assess: a) a panel of innate and adaptive cytokines and chemokines using a commercial multiplex assay, b) immune cell phenotypes using high dimensional flow cytometry and c) viral antibodies to establish prior/recent infections and cross-reactivity using targeted ELISA assays developed for antibodies to other human beta-coronaviruses
Secondary Outcomes
- Identify biological, health and sociodemographic predictors of SARS-CoV-2 infection susceptibility and severity(12 months)
- Sex-and-gender-based analysis(12 months)
- SARS-CoV-2 infection, severity, transmission and immunity. Prevalence and severity of infection(12 months)
- Understand the psychosocial, health and equity impacts of the COVID-19 pandemic(12 months)